Insanitary Conditions Violations
You manufacture [redacted], a drug product intended for vaginal use as a hemostatic solution to stop bleeding after cervical biopsies. During the inspection, our investigator observed filthy conditions in your facility, including dirty equipment and utensils covered with unknown residue. A large metal roll-up door at the entrance to your facility was open to the outdoors, while an open pot you use as a mixing vessel contained in-process material and was not covered. The insanitary conditions observed at your facility failed to protect drug products from contamination with filth.
1. Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).Cooking utensils? That sounds... yucky.
Our investigator documented that you have an employee food preparation area within your drug manufacturing area with no separation between open manufacturing equipment, cooking utensils, and personal-use items. The practices observed at your facility, which was observed open to the outdoors, increase the likelihood of your drug products becoming contaminated.